Inactivated rabies vaccines: Standardization of an <i>in vitro</i> assay for residual viable virus detection

Published on 2020-03-25T17:33:57Z (GMT) by
<div><p>Human rabies, a neglected viral zoonosis, is preventable through domestic animals vaccination and post-exposure prophylaxis using inactivated rabies vaccines. During vaccine production, several mandatory <i>in vivo</i> quality control trials, such as potency, live virus, and safety, are responsible for the use of large numbers of laboratory animals. Over the years, global organizations encouraged the development of alternative methods to reduce, replace and refine the use of animals in the pharmaceutical industry. In this study we standardized an <i>in vitro</i> assay for determination of residual live virus combining viral isolation techniques with direct immunofluorescence detection and viral quantification by a molecular method. Standardization of viral recovery steps and quantification by RT-qPCR were performed and the combined method was shown to be 3 fold more sensitive than the <i>in vivo</i> assay. It was possible to identify viral suspensions cultures, which still had residual viable rabies virus particles, evidencing the importance to implement this method in quality control schemes of rabies vaccine production. In addition, this developed assay is more practical, inexpensive and less time consuming, producing results in just 4 days, which may allow greater agility in the internal quality control of the vaccine. The <i>in vitro</i> method may reduce 2/3<sup>rd</sup> of laboratory animals numbers used for this purpose, since it can be applied in the intermediate quality control of inactivated rabies vaccine production.</p></div>

Cite this collection

Moreira, Beatriz Lourenço Correia; Gimenez, Ana Paula Lappas; Inagaki, Jorge Minor Fernandes; Raboni, Sonia Mara (2020): Inactivated rabies vaccines: Standardization of an in vitro assay for residual viable virus detection. PLOS Neglected Tropical Diseases. Collection. https://doi.org/10.1371/journal.pntd.0008142